The present invention relates in general to a mapping system and method useful for mapping identifying anatomic members such as tissues, nerves, vessels or any other anatomic body part. This mapping can assist in the manipulation of a medical instrument, catheter, or the like, either under direct or robotic control.
Part of the xe2x80x9cartxe2x80x9d of surgery is knowing where to cut and where the xe2x80x9cdanger zonesxe2x80x9d are located. The surgeon relies on visual clues to determine where important anatomical structures are located. He also relies upon palpation. Landmarks such as bony prominence, ligament insertions, position of muscles and solid organs, and other landmarks guide the surgeon during tissue dissection (also referred to as transection).
One of the major complications of surgery is inadvertent transection of sensory nerves, motor nerves, arteries, veins and hollow viscus. In most cases this occurs when key structures are poorly visualized by the surgeon, or due to inexperience or altered anatomical structures (e.g., surgical landrnarks). Blunt dissection is performed either manually using the fingers or using an instrument, and sharp dissection is performed using a scissors, electrical-surgical device, or scalpel.
A common side effect or complication of much surgery is neurological trauma, paresis or permanent paralysis occasioned by the severing of nerves. Over 5% of major head and neck surgeries (e.g., parotidectomy) result in damage to the facial nerve resulting in weakness of the facial muscles or partial paralysis of the face. A frequent consequence of prostate surgery is damage to the sacral nerves, which control erectile function and ejaculation. Almost 40% of men undergoing prostatectomy are left impotent or have significant problems with erectile function.
Inadvertent perforation of the aorta, or of the superior or inferior Vena Cava, can cause a major hemorrhage which may result in death. The Vena Cava may be ruptured during dissection of the spleen or resection of tissues on the posterior surface of the liver. Transection of smaller arteries and veins, while less life-threatening, are a cause of significant morbidity, often require transfuision to compensate for blood loss, and can significantly increase the length of hospitalization following a procedure. Similarly, transection of the ureter results in major morbidity, requires multiple operations to correct, may result in renal failure and significantly impairs quality of life. Perforation of other hollow viscus, such as the bowel or bladder wall, may result in peritonitis and death.
Electrical transducers are commonly used in medical practice to measure electrical impulses within nerve bundles. These instruments include: electroencephalograms (EEG), electrocardiogram (EKG), electromyography (EMG), and others. All these devices have in common the ability to measure electrical impulses generated by nerve structures. The electrical fields vary with motor nerve, sensory nerve, the degree of myelinization and the number of nerves in the particular neural bundle. The electrical impulses are typically in the form of a waveform that is examined and interpreted by a surgeon or physician. Such a readout is primarily used as a diagnostic tool in determining irregularities in organs such as the heart or brain.
Subtle temperature variations also exist within different anatomical compartments. Venous blood returning from an extremity is cooler than arterial blood. Sites of infection tend to be slightly warmer than healthy tissues. Abscess pockets tend to be somewhat cooler than surrounding tissues. These temperature variations are generally below the threshold of human proprioception. The variations can be less than a tenth of a degree. A number of different thermistors, which can measure temperature variation to a hundredth of a degree, are used in medicine to monitor vital signs, cardiac output, and other functions. Again, such use is primarily diagnostic.
Gallium and technetium, as well as other isotopes, are used for tracking infection, lymphatic drainage and to provide contrast during magnetic resonance imaging (MRI) These isotopes are gamma emitters and, in general patients undergoing these scans are evaluated by gamma counters which then measure the degree of radioactive uptake. This data is then graphically displayed as an x-ray film.
During sentinel node biopsy, lymphoscintigraphy is used to localize the regional draining nodal basin in breast cancer and melanoma therapy. A small incision is then made in the skin overlying the xe2x80x9chotxe2x80x9d node. Blunt and sharp dissection is used to reach the nodal basin. A sterile-wrapped Geiger counter is then inserted into the wound to identify the affected node(s). Further dissection and Geiger counter testing is performed until the radioactive sites are fully identified and resected. This is a time-consuming and laborious process, with the operative field landmarks and lymph nodes shifting in space with each insertion/removal of instruments.
In these various techniques, there is a need for a better method of identifying anatomic structures or parts, particularly when these structures or parts are not visible to the surgeon""s eye. By identifying these structures or parts, one can avoid the aforementioned problems that can lead to tissue, organ, or nerve damage, paresis, permanent paralysis, or other injuries that impair the quality of life of the patient.
In one embodiment, what is sensed is a non-visible field and what is provided is a combined display of virtual and visual images. In this embodiment, a system is provided for generating the display of a body structure. The system includes a sensor positionable at an internal body site for sensing a non-visible field of a body structure at the site and generating a sensor signal indicative of the field. A transformation system transforms the sensor signal into virtual image data. A source of visual image data for the site is also provided. A visual system enables combined display of the visual image data and the virtual image data.
According to a corresponding method, steps are provided for sensing at an internal body site a non-visible field of a body structure at the site and generating a sensed signal indicative of the field, transforming the sensed signal into virtual image data, providing visual image data for the site, and displaying in combination the visual image data and the virtual image data.
In another embodiment, what is sensed is a non-visible field by a sensor positioned with a computer-controlled instrument, and what is provided is virtual image data. In this embodiment, a system is provided for obtaining virtual image data of a body structure. The system includes a computer-controlled instrument for positioning a sensor at an internal body site, the sensor sensing a non-visible field of a body structure at the site and generating a sensor signal indicative of the site, and a transformation system is provided for transforming the sensor signal into virtual image data.
According to a corresponding method, steps are provided for positioning by computer control a sensor at an internal body site, sensing a non-visible field of a body structure at the site and generating a sensor signal indicative of the field, and transforming the sensor signal into virtual image data.
In another embodiment, what is sensed is a non-visible field and what is provided is a tactile feedback for controlling manipulation of a medical implement. In accordance with this embodiment, a system is provided for controlling manipulation of a medical implement including a sensor positionable at an internal body site for sensing a non-visible field of a body structure at the site and generating a sensor signal indicative of the field, a transformation system for transforming the sensor signal into a feedback signal, and a control system, including a haptic user interface, for manipulating a medical implement at the site, the control system receiving the feedback signal and in response thereto providing a tactile signal at the user interface.
In accordance with the corresponding method, there are steps provided for sensing a non-visible field of a body structure at an internal body site and generating a sensed signal indicative of the field, transforming the sensed signal into a feedback signal, and utilizing the feedback signal to provide a tactile signal at a haptic user interface for controlling manipulation of a medical implement at the site.
In another embodiment, what is sensed is a visual image and what is provided is a tactile feedback for controlling manipulation of a medical implement. In accordance with this embodiment, a system is provided for controlling manipulation of a medical implement including a sensor positionable at an internal body site for sensing a visual image of a body structure at the site and generating a sensor signal indicative of the image, a transformation system for transforming the sensor signal into a feedback signal, and a control system, including a haptic user interface, for manipulating a medical implement at the site, the control system receiving the feedback signal and in response thereto providing a tactile signal at the user interface.
In accordance with the corresponding method, there are steps provided for sensing a visual image of a body structure at an internal body site and generating a sensed signal indicative of the image, transforming the sensed signal into a feedback signal, and utilizing the feedback signal to provide a tactile signal at a haptic user interface for controlling manipulation of a medical implement at the site.
Various aspects of the present invention are described herein in a number of different embodiments. Many of these embodiments relate to a mapping system and method for identifying the location of certain anatomic areas such as, but not limited to, nerves or nerve bundles. This mapping involves the translation of certain sensed parameters (also referred to as stimuli) into response parameters. The sensed parameters include non-visible data (electromagnetic, thermal, infra-red, radioactive, etc.), and in other embodiments visible data and/or force sensed data. The response parameters include a display device, an audible device, a vibratory device and force feedback to a haptic interface.
Identification of the anatomic area may be used for the purpose of avoiding the area (such as in guiding a tissue dissection), or for the purpose of targeting, locating or guiding toward the anatomic area. Also, the identification may be employed in either a robotic system or a non-robotic system (e.g., in association with a hand-held instrument, such as a laparoscopic instrurnent). A telerobotic system usually is comprised of master and slave stations including, on the master side, a haptic interface and a display device, and, of the slave side, a controllable medical implement. Here a sensor is provided on the slave side, at the anatomic site of interest. The sensor detects, inter alia, electric, thermal, infra-red and radioactive fields, and is preferably, but not necessarily, carried at the distal end of the medical implement. The sensing may be by manual scanning or may be under computer control. Furthermore, the sensing may be either to establish a database, particularly for mapping non-visible fields to a display, or may be used in a real time mode, particularly for feedback control to the master haptic interface.
One aspect of the present invention is to provide, in addition to a visual image of an anatomic site of interest, a virtual image or boundary of an invisible (also referred to as non-visible) anatomic structure at the site, such as nerves or nerve bundles. The virtual image or boundary may be established by sensing, for example, an electric field, thermal field, or radioactive field associated with the anatomic structure. The sensed field may also be used in xe2x80x9creal timexe2x80x9d to control, for example, a haptic (relating to or based on the sense of touch) interface by providing tactile feedback to the surgeon regarding the hidden anatomic structure.
In accordance with one aspect of the invention there is provided a system for sensing a non-visible field to provide a tactile feedback to a haptic interface. This system may include a surgical implement, including for example an end effector or tool, to perform a predetermined surgical procedure at an anatomic body site. A controller is disposed between the surgical implement and the haptic interface and a sensor preferably, but not necessarily carried by the end effector, for sensing a non-visible field at the body site. The controller is responsive to manipulations at the haptic interface by an operator to control the surgical implement in performing the surgical procedure. The controller also is responsive to a feedback signal which is a function of a sensed parameter of the non-visible field. This signal is fed back to the haptic interface to provide a tactile indication to the operator as to the location of the anatomic structure that generated the field.
In accordance with various aspects of the present invention, a non-visible field may comprise an electrical field, a thermal field, a radio-active field, or an IR field. Also, considered as falling within the scope of the present invention are any other no-visible fields. Generally speaking, by the term xe2x80x9cnon-visiblexe2x80x9d reference is being made to a particular field established in the anatomy, either inherent or via stimulation, and that is not observable by the surgeon by the naked eye, such as by way of an endoscope. A xe2x80x9cfieldxe2x80x9d refers to a series of data points sensed over a particular area and representative of such parameters as electric field, temperature, or radio-activity. A xe2x80x9cfieldxe2x80x9d may also be identified as directly sensed or inferred sensory information which constructs a data set of values.
xe2x80x9cNon-contactxe2x80x9d as used in connection with haptic feedback control refers to non-visible as well as other types of sensed effects that are not based upon direct physical contact between the sensor and the anatomic member or part.
In accordance with various aspects of the invention, the sensed or predetermined parameter may comprise a magnitude of the field. Also, the sensor may be a voltmeter, thermistor, gamma detector, IR detector, or any other type of sensing device that would sense the particular non-visible field. The aforementioned anatomic body member may comprise a nerve or nerve bundle, vascular vessels, or virtually any other body part.
In accordance with still another aspect of the invention, there may be provided a stimulator for stimulating the anatomic body member. The stimulator may be controlled from the controller so as to emit a predefined electrical stimulation signal that is coupled to energize the body member. The detected stimulation signal is fed back to the controller to identify the body member based upon a recognizable pattern. The pattern may be a repetitive pattern establishing an anatomic body member signature.
In accordance with another aspect of the invention, the system may include a display, which may be coupled with an optic element, for display the area at the anatomic body site. A controller receives a signal from the sensor and establishes on the display a map of the field (a virtual boundary defined by the map) about an anatomic body member. Moving the sensor to a plurality of locations in juxtaposition to the anatomic body member generates a map including boundaries of the field relative to the anatomic body site. The display is observable by the surgeon for displaying both a visual image and a virtual image, the virtual image being representative of the map boundaries and essentially representative of the position of the non-visible field.
In accordance with another aspect of the invention, there is provided a medical system comprising a surgical implement including an end effector used to carry out a predetermined surgical procedure at an anatomic body site, a sensor for sensing a non-visible field that is established associated with a member at the anatomic body site, and a display. Further included is a controller for receiving signals from the sensor and establishing a map of the field about the member at the anatomic body site. The controller couples to the display and establishes on the display both a visual image of the area at the anatomic body site as well as a virtual image representative of a boundary defined by the map and thus defined by the non-visible field.
In accordance with another aspect of the invention, there may also be provided a haptic interface for control of the surgical implement. A controller coupled to the haptic interface controls an operator""s action at the haptic interface as a function of a predetermined parameter of the non-visible field.
In accordance with another aspect of the invention, there is provided a telerobotic surgery system having a slave station at which a surgical implement is disposed and a master station with a surgeon interface at which manipulations occur to control the surgical implement. Apparatus is provided for sensing a non-visible field associated with an anatomic body member in which the non-visible field distinguishes the anatomic body member from the surrounding area. The apparatus can be used for generating a tactile feedback signal at the surgeon interface. Such apparatus may comprise a sensor carried by the surgical implement for detecting the non-visible field generated from the anatomic body member. Also included is a controller coupled from the sensor, responsive to the magnitude of the field, for feeding back to the master station a control signal to the surgeon interface so as to provide a tactile response to the surgeon based upon the magnitude of the detected field.
In accordance with another aspect of the invention, there is provided a telerobotic surgery system having a slave station at which a surgical implement is disposed and a master station with a surgeon interface at which manipulations occur to control the surgical implement. An apparatus is provided for mapping a non-visible field associated with an anatomic body part and in which the non-visible field distinguishes the anatomic body part from other anatomic structures. This apparatus includes a sensor for detecting the non-visible field generated from the anatomic body part, a controller coupled from the sensor, responsive to the disposition of the sensor at a plurality of locations in juxtaposition to the anatomic body part, to generate a map including boundaries of the field relative to other anatomic body structures, and a display (coupled to the controller) observable by the surgeon for displaying both a visual image of the area about the anatomic body part as well as a virtual image representative of the map boundaries.
In accordance with another aspect of the invention, there is provided a medical device that comprises a surgical implement having an end effector used to carry out a predetermined surgical procedure at an anatomic body site that includes an anatomic body member that is not visible to the surgeon. The medical device includes a handle member operated so as to control the surgical implement and end effector, a sensor for detecting a non-visible field that is associated with the anatomic body member and that demarcates a boundary of the field of the anatomic body member, and a controller coupled from and responsive to the sensor for providing at the handle a tactile indication to the surgeon based on a predetermined parameter of the field.
In accordance with another aspect of the invention, there is provided a medical system useful in identifying an internal anatomic body member that is not visible to the surgeon by direct or indirect optical means. This system enables improved control by the surgeon of certain surgical procedures. The system comprises a sensor for sensing a non-visible field that is associated with an anatomic body member. By way of example, this non-visible field may be an electrical field about a nerve or nerve bundle. A controller is employed coupled from the sensor and responsive to signals representative of different locations of sensing relative to the anatomic body member so as to establish a map including boundaries of the field relative to other juxtapositioned anatomic structures. A display, observable by the surgeon, is coupled to the controller for visually displaying the virtual field boundaries based upon the non-visible field.
In accordance with still another aspect of the invention, there is provided a method of tactile feedback to a surgeon. This method includes disposing a medical implement at an anatomic body site in a position to effect, by a manipulator, a predetermined medical procedure. Next is a step of sensing a non-visible field associated with an anatomic body member which distinguishes the anatomic body member from the surrounding area at the anatomic body site. Lastly, is a step of generating a tactile feedback signal to the manipulator based upon a parameter of the non-visible field. This method may also include a step of stimulating the anatomic body member; this stimulation may include emitting a predefined electrical stimulation signal coupled to energize the anatomic body member.
In accordance with a further aspect of the invention, there is provided a method of identifying an internal anatomic body member that is not visible to a surgeon by direct optical means so as to enable improved control by the surgeon of a surgical procedure. This method includes sensing a non-visible field that is established and associated with the anatomic body member and controlling the sensing so as to be responsive to signals representative of different locations of sensing relative to the anatomic body member. This sensing establishes a map including virtual boundaries of the sensed field relative to other juxtapositioned anatomic structures. Last is the step of displaying, on a display, observable by the surgeon, the anatomic body site as well as the virtual field boundaries. This method may also include stimulating the anatomic body member.
In accordance with still another aspect of the invention, there is provided a medical system that comprises a sensing device for obtaining a visual image of an anatomic body site, a medical implement and a manipulator controlled by an operator for control of the implement at the anatomic body site. A controller intercouples the sensing device and the manipulator and includes a mapping component for translating predetermined characteristics of the visual image into a signal for controlling action at the manipulator.
In accordance with further aspects of this medical system, the signal for controlling action at the manipulator may comprise a force signal or a vibration signal. The sensing device may comprise an endoscope. The controller may control actions at the manipulator as a function of the position of the surgical implement within the anatomic body site. The surgical implement may comprise a surgical instrument with an end effector or a catheter or any other type of surgical implement. The manipulator may include a hand-held instrument or may comprise a haptic interface of a tele-robotic system.
In accordance with another aspect of the invention, there is provided a medical system that comprises a sensing device for obtaining a visual image of an anatomic body site, a surgical implement, and a manipulator controlled by a surgeon for control of the surgical implement at the anatomic body site. An audible device is employed in the system along with a controller intercoupling the sensing device and the audible device. This controller includes a mapping component for translating predetermined characteristics of the visual image into a signal for controlling the audible device.
In accordance with further aspects of the invention, the predetermined characteristics may represent an outline of an anatomic body member. The controller may control the audible device as a function of the position of the surgical implement within the anatomic body site and relative to the anatomic body member. The audible device is sounded when the surgical implement comes within a predefined proximity to the anatomic body member, so as to signal that the surgical implement is too close to the anatomic body member.
In accordance with still another aspect of the invention, there is provided a medical system that comprises a surgical implement, a manipulator, controlled by an operator for control of the surgical implement at an anatomic body site, and a force sensor for detecting by a direct contact a force imposed on the surgical implement at the anatomic body site. Also included is a visual display observable by the operator as well as a controller intercoupling the force sensor and the visual display and including a mapping block for translating predetermined characteristics from the force sensor into a signal for controlling the content of display on the visual display.
In accordance with further aspects of the invention, the controller controls the display content as a function of the position of the surgical implement within the anatomic body site. The force sensor may be carried directly on the surgical implement or may be at some other defined location relative to the surgical implement. The controller is responsive to a force signal from the force sensor for highlighting an area of the visual display corresponding to a location of the surgical implement. The highlighting may also include providing an indicia on the visual display representative of an area where a force of greater than a predetermined threshold force is sensed.
In accordance with a further aspects of the invention, there is provided a medical system that comprises a surgical implement, a manipulator controlled by an operator for control of the surgical implement at an anatomic body site, and a force sensor for detecting by direct contact a force imposed on the surgical implement at the anatomic body site. Also included in the system is a controller intercoupling the force sensor and the manipulator and including a mapping block for translating predetermined characteristics from the force sensor into a signal for controlling vibration at the manipulator.
In accordance with further aspects of this system, the controller controls the manipulator as a function of the position of the surgical implement within the anatomic body site. The force sensor may be carried by the surgical implement or may be at another location. The controller is responsive to a force signal from the force sensor for controlling the manipulator as a function of the measured force level.
In accordance with a further aspect of the invention, there is provided a medical system that comprises a surgical implement, a manipulator controlled by an operator for control of the surgical implement at an body site and a force sensor for detecting by direct contact a force imposed on the surgical implement at the body site. Also included in the system is an audible device and a controller for intercoupling the force sensor and the audible device and including a mapping component for translating predetermined characteristics from the force sensor into a signal for controlling the audible device.
In accordance with further aspects of this system, the controller is responsive to a force signal from the force sensor for controlling the magnitude of an audible signal from an audible device as a function of the magnitude of the force signal. The audible signal may be generated only when the force signal exceeds a preselected threshold.
In accordance with another aspect of the invention, there is provided a medical system comprising a surgical implement, a manipulator controlled by an operator for control of the surgical implement at an anatomic body site and a sensing device for sensing a non-visible field generated from an anatomic body member disposed at the anatomic body site. The system also includes a visual display and a controller intercoupling the sensing device and the visual display and including a mapping component for translating predetermined characteristics of the non-visible field from the sensing device into a signal for controlling the content on the visual display.
In accordance with other aspects of the above system, the manipulator intercouples with the controller and the controller is responsive to actions at the manipulator to control the surgical implement in carrying out a surgical procedure. The controller may establish on the display both a visual image of the area at the anatomic body site as well as a virtual image representative of a boundary defined by the mapping component and relating to the non-visible field. The non-visible field may be an electric field (which as used herein includes an electromagnetic field), a thermal field, a radioactive field, an IR field, or any other type of non-visible field.
In accordance with the various systems of the invention, the sensing device may comprise a voltmeter, a thermistor, a gamma counter, an IR detector or any other type of field detecting device. Also, a further sensing device may be used for obtaining a visual image of the anatomic body site wherein the controller translates predetermined characteristics of the visual image into a signal for controlling actions at the manipulator. The signal for controlling action at the manipulator may comprise a vibration signal. Also, an audible device may be employed wherein the controller translates predetermined characteristics of the visual image into a signal for controlling the audible device. The aforementioned system may also include a force sensor for detecting by direct contact a force imposed on the surgical implement at the anatomic body site. The controller may translate predetermined characteristics of the force signal into a signal for controlling the content on the visual display. The controller may translate predetermined characteristics of the force sensor into a signal for controlling vibration at the manipulator. If an audible device is employed, the controller may translate predetermined characteristics from the force sensor into a signal for controlling the audible device.
In accordance with another aspect of the invention, there is provided a medical system that comprises a medical implement, a manipulator controlled by an operator for control of the medical implement at an anatomical body site, and a sensing device for sensing a non-contact field generated from an anatomic body member disposed within the anatomic body site. A controller intercouples the medical implement, manipulator and sensing device and includes a mapping component for translating predetermined characteristics of the non-contact field from the sensing device to a signal for controlling actions at the manipulator.
In accordance with further aspects of this system, the signal for controlling action may control a tactile feedback to the operator. The signal for controlling actions may control a vibration level at the manipulator and there may also be provided a second sensing device for obtaining a visual image at the anatomic body site. This may include an endoscope.
In accordance with still a further aspect of the invention, there is provided a medical system that comprises a surgical implement for carrying out a predetermined surgical procedure at an anatomic body site, a sensing device for sensing a non-visible field generated from an anatomic body member disposed within the anatomic body site, and an audible device. A controller intercouples the sensing device and the audible device and includes a mapping component for translating predetermined characteristics from the sensing device into a signal for controlling the audible device. A manipulator may be provided for controlling the surgical implement at the anatomic body site. The controller is responsive to the magnitude of the sensed field for controlling the audible signal from the audible device as a function of the magnitude of the sensed field.
Numerous other features of the present invention should now become apparent upon a reading of the following detailed description: